Letter from Technical Officer - March 13, 2003

Extruder challenge and airborne contamination risks studies

Dear BFS-member,

As the Technical Officer of the BFS IOA, I have followed closely the recent discussions around aseptic processing guidelines and the impact on our industry. I have presented our views on the recently released FDA concept paper on aseptic processing at two PDA conferences (New Orleans in Dec-02 and in Prague, Feb-03). To follow up on these presentations, we finally submitted our written comments to the FDA on March 6, 2003.

The concept paper released from the FDA last September, are indicating where the regulators are heading, and to be honest with you, it does not look too good. As BFS users or providers, we know of the robustness and capability of our process. BFS is an advanced aseptic process which is generally thought to be superior to traditional aseptic processing when it comes to contamination risks. This, however, is not reflected in the FDA concept paper, since the same or even tougher demands are mandated in the Appendix 2, covering BFS processing. How come?

Regulators like the FDA or EU authorities are looking for, and are willing to promote, new and more advanced aseptic technology; this is my firm belief. But they will only do so if they are convinced about the superiority of the process over current technology. In lack of such data, they will continue to mandate the same set of demands as for traditional technology. We all think the set of demands which is put upon us from regulators are high, and sometimes too high. The only way to attack this problem is to convince ourselves, and the regulators that these high demands are not necessary to remain in a state of control. In our comments to the FDA concept paper we are suggesting the use of risk assessment of contamination risks. However, such risk assessments must be based on sound science to be of any worth. Only when we are willing to put money and time into science based investigations and only when we are willing to publish such data in internationally respected journals will we be able to convince the regulators of the superiority of our process.

Still today, more than 25 years after the first pharmaceutical BFS machines came into operation, there are very few publications on BFS processing and its risks worth mentioning.

We are all sharing the same wish, to be able to show without any doubt, that BFS is as excellent as we all think. Together, with combined efforts, I think we can come closer to that goal. This is the very core of the BFS IOA, to share the same goal and to work together to achieve it. It is said that nothing unites like a common enemy, and although I do not see the regulators as our enemy, I think you see my point.

At recent BFS IOA meetings we have discussed various possibilities for scientific studies. Recently, the hot topics have been a common way to address extruder challenge studies and how to make studies of airborne contamination risks. Studies of this nature do not come cheap, and the resources of the BFS IOA are limited. I am therefore interested to hear about your company’s willingness to pay a sum of e.g. 10,000 Euro, devoted to studies aimed at bringing us closer to our common goal. The more companies that are willing to contribute, the more studies will be made and published. Naturally, we would need to present detailed study plans for your review before anything can be decided.

As an international association, we should strive for obtaining generic ways of assessing the critical parts of the BFS process. I feel it is relevant to concentrate on the following parts:

  • The extruder and its ability to reduce spore- and endotoxin levels
  • Airborne contamination via intrusive air (what are the risks of airborne contamination during parison cutting, shuttling and filling)

What is your company standpoint in supporting studies within these areas (any preferences)?

Short term, the board of the BFS IOA are investigating possibilities to discuss directly with the FDA and potentially influence them to accept our arguments described in our comments to the concept paper. If such a meeting would come true we would quickly need to gather some data to support our views. Although media fill data will not prove anything, the FDA has expressed interest in seeing collected data for a longer period of time from the BFS industry.

Would your company be willing to send long-term media fill data and/or data on sterility based recalls to myself? Data will of course be treated anonymously.

Please help the BFS IOA and yourselves to prove your case, and please let us know your answer before the end of March, if possible.

I hope to see you all at our AGM in Manchester, U.K.

Yours truly,

Anders Löfgren, Ph.D.
Global Technical Officer,
The Pharmaceutical BFS International Operators Association